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Regulatory Affairs Manager

hace 2 meses

Madrid, Madrid, España Innovaderm A tiempo completo
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Innovaderm. As a key member of our regulatory affairs department, you will be responsible for ensuring the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations, good clinical practices, and to the Sponsor's satisfaction.

Key Responsibilities
  1. Leadership and Strategic Planning: Provide leadership on regulatory activities leading to global startup of clinical trials, plan and assign work, oversee performance of direct reports, and perform annual reviews.
  2. Team Management: Manage a team of Regulatory Affairs employees, including performance management and talent conversations, ensure adequate resources (headcount, experience, training) to sustain regional activities of the regulatory affairs group.
  3. Regulatory Compliance: Ensure regulatory affairs activities are delivered on time, within budget, and in compliance with SOPs and regulations, identify and report out of scope activities to project team.
  4. Regulatory Submissions: Oversee resource assignments and participate in preparation, review, submission, maintenance, and tracking of regulatory authority and IRB/IEC submissions, ensure adequate review of activities performed outside of the company by subcontractors to ensure high quality standards before submission.
  5. Communication and Collaboration: Provide strategic advice on regulatory submissions and act as point of contact for Sponsors and subcontractors/project teams, support project teams with oversight of submissions in global regions, such as Asia Pacific.
  6. Document Management: Prepare and/or review master and country-specific Informed Consent form documents, oversee labeling review of clinical trial drug supplies to ensure conformity with regional regulations.
  7. Quality Assurance: Oversee regulatory review of essential documents to authorize shipment of investigational product to clinical sites, oversee activities associated with clinical SAE reporting.
  8. Process Improvement: Participate in the preparation and review of SOPs and associated tools, ensure centralization of start-up global regulatory information and maintenance of the regulatory intelligence database.
  9. Industry Knowledge: Maintain familiarity with relevant current industry practices and regulatory requirements, participate in regulatory watch activities.
  10. Business Development: Contribute to the development of project budgets and business development proposals.
Requirements
  1. Education: Bachelor's degree (or equivalent) in life sciences or scientific discipline.
  2. Experience: At least 5 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry.
  3. Regulatory Knowledge: Excellent knowledge of applicable regional/national country regulatory and IRB/IEC guidelines and regulations.
  4. Leadership and Management: Experience in team leadership; line management experience is an asset.
  5. Communication and Collaboration: Excellent knowledge of Microsoft Office suite, fluent in English with excellent oral and written communication skills; additional languages are an asset.
  6. Problem-Solving and Analytical Skills: Ability to organize departmental work, prioritize assignments, and work under pressure, attention to detail and accuracy in work.
  7. Adaptability and Flexibility: Versatile and comfortable in a multitasking environment, respect established timelines, expectations, priorities, and objectives.
  8. Industry Knowledge: Good knowledge of good clinical practices, and applicable Health Canada and FDA regulations/guidelines.
About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks:

  • Flexible work schedule
  • Permanent full-time position
  • Company benefits package
  • Ongoing learning and development

About Innovaderm: Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings, our organization has benefited from a solid reputation for the quality of its research and services, exceeding the expectations of our clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Innovaderm only accepts applicants who can legally work in Spain.